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510(k) K250889

EXULT Knee Replacement System by Corentec Co., Ltd. — Product Code JWH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 17, 2025
Date Received
March 25, 2025
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Device Class
Class II
Regulation Number
888.3560
Review Panel
OR
Submission Type

Other clearances by Corentec Co., Ltd.

  • K242401 — EXULT Knee Replacement System (September 12, 2024)
  • K242046 — EXULT Knee Replacement System (August 1, 2024)
  • K223828 — BENCOX Delta Option Heads (March 16, 2023)
  • K223223 — BENCOX Mirabo Z Cup Cortinium (February 27, 2023)
  • K222278 — LOSPA TKR System Instrumentation, EXULT TKR System Instrumentation (August 26, 2022)
  • K210614 — BENCOX Mirabo Z Cup Cortinium (May 24, 2022)
  • K220468 — BENCOX Mirabo Cup System (May 18, 2022)
  • K212034 — LOSPA TKR System (December 9, 2021)
  • K211866 — Bencox THR System (July 14, 2021)
  • K201851 — EXULT Femoral component trial - Left, EXULT Femoral component trial - Right (July 30, 2020)

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  • K253314 — Freedom Infinia™ Total Knee System (October 29, 2025)
  • K253144 — Freedom® Total Knee System – Titan PCK Components (October 22, 2025)
  • K252725 — Stem Extension Line (U2 Total Knee System—PSA Type) (September 25, 2025)
  • K251554 — Materialise TKA Guide System (July 14, 2025)
  • K251776 — EMPOWR Revision Knee™ (EMPOWR Revision VVC+, e+ Tibial Insert) (July 8, 2025)
  • K251241 — EMPOWR Revision Knee™ (EMPOWR Revision Knee™ Symmetric TT Cones) (July 2, 2025)
  • K251717 — Freedom® Total Knee System – Titanium Tibial Base Plate (June 26, 2025)